Alaris System Pump module (LVP), Mechanism Sub-assembly and Kit Assembly 의 리콜

Recall

RC-2017-RN-01312-1

Class I

2017-11-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01312-1

Becton dickinson (bd) has identified an issue with the alaris pump module regarding increased or decreased flow rates that have occurred in pumps with mechanical assemblies manufactured between november 2011 and march 2012.The component of the alaris pump module causing this issue is the bezel assembly, specifically the bezel posts. the affected posts may have cracking in one or more posts that connect the mechanism frame to the bezel assembly. separation of one or more bezel posts may prevent the device from delivering an accurate amount of fluid through the pumping cycle, resulting in an over or under infusion.Zero reports relating to this issue have been received in australia.

BD has assessed the risk of this issue and determined that the affected product can still be used until this correction is carried out. However, BD strongly recommends that clinicians increase their level of vigilance when using impacted pumps. Additionally, clinicians should remove the pump from service if it shows signs of infusion at an unexpected rate. Use non-affected, or remediated, devices in high risk areas if possible. In addition, to the best of BD’s ability, BD will work with customers to identify and mark individual pumps that have not yet been remediated. BD will replace the mechanical assembly of the affected serial numbers at no charge. BD will be in contact with all affected customers to initiate the scheduling process for the remediation.